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Medicare agency accepts Novartis, Gilead gene therapies for cancer treatment

Medicare recipients will now have access to innovative CAR-T cell therapies for cancer after the Trump administration cleared a final rule accepting the medicines for use in the program.

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Chimeric Antigen Receptor-T cell, or CAR-T cell therapies, are a form of gene therapy that use a patient's modified immune cells to fight cancer. The therapies modify T cells, boosting their ability to attach to and fight cancer cells.

The U.S. Food and Drug Administration has approved two of the therapies Novartis AG's Kymriah and Gilead Sciences Inc.'s Yescarta to treat certain types of blood cancers.

Medicare will now cover the therapies' use in healthcare facilities for cancers as approved by the FDA and for off-label use in cancers that are recommended by the Centers for Medicare and Medicaid Services. Off-label use is a common practice in the medical industry, where drugs are used to treat diseases that are not specifically approved for that condition.

To receive the coverage, patients must be enrolled in the FDA's risk evaluation and mitigation strategies program, which follows users of CAR-T cell therapies after administration.

The CMS said Medicare patients receiving the treatment must be closely monitored, and the agency supports developing safe, effective CAR-T cell therapies.

"Today's coverage decision provides consistent and predictable patient access nationwide," said CMS Administrator Seema Verma. "CMS will work closely with our sister agencies to monitor outcomes for Medicare patients receiving this innovative therapy going forward."

CAR-T cell therapies have been under consideration by the CMS for inclusion in the Medicare program since May 2018, after a formal request was made to add them. The agency proposed to include the medicines in the program in February, with coverage originally expected to begin in May.

The list price for Novartis' Kymriah is $475,000 for a single course of treatment. Yescarta's list price is $373,000. However, the government reimburses only about half of those amounts under its hospital payment policies.